Senior Quality Engineering Manager, Combination Product Nearing FDA Clearance | 3663900

Run quality on a combination product through FDA clearance and first commercial launch, at a company small enough that your judgment sets the program. Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Why this role A build seat, not a maintenance seat. Our client is a small medical technology team taking a combination product through FDA clearance and into commercial manufacturing, and the quality program has to be ready before the product is. You set the priorities, run the quality system, and direct the outside validation firms that carry much of the equipment and process work, working directly with the executive team. Who thrives here You are a senior quality engineering manager or quality manager ready to run quality for a whole program. When there is more work than time, you decide what matters and can say what you chose not to do. You tell leadership about a problem before anyone asks. This is not for you if you need a large team, a fully built system, or direction on each decision. What you will own The quality system day to day: CAPA, nonconformances, document control, training, supplier controls and audit readiness. The validation program for equipment, processes and test methods, including the outside firms that execute much of it. Quality engineering through scale-up and the first commercial builds, plus the risk files behind clearance and launch. Straight, early reporting to leadership on where quality stands. What you bring Ten or more years in medical device or combination product quality in manufacturing, including time leading quality engineers. IQ, OQ, PQ and process validation you have written and run yourself, not only approved. ISO 13485 and FDA's quality system regulation in practice, including FDA inspections or notified body audits. Experience directing contractors or an outside validation firm, and a degree in engineering or science. A plus: combination product experience, sterilization validation, or ISO 13485 lead auditor certification.